Disease progression parameters and uses thereof for evaluating multiple sclerosis

Abstract

Methods, systems and kits to detect and / or quantify disease progression in a subject having a progressive form of MS are disclosed.

Description

RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application No. 61 / 682,521, filed Aug. 13, 2012, the contents of which are incorporated herein by reference in their entirety.BACKGROUND OF THE INVENTION[0002]Multiple sclerosis (MS) is an inflammatory disease of the brain and spinal cord characterized by recurrent foci of inflammation that lead to destruction of the myelin sheath. In many areas, nerve fibers are also damaged. Inflammatory activity in MS patients tends to be highest in the initial phase of disease.[0003]Emerging data demonstrate that irreversible axonal loss occurs early in the course of MS. Transected axons fail to regenerate in the central nervous system (CNS) and therefore, early treatment aimed at suppressing MS lesion formation is of paramount importance. As early as disease onset, axons are transected in lesions with active inflammation (Trapp et al. (1998) N Engl J Med 338: 278-285; Bjartmar et al. (2001) Curr Opin Neurol 14: 27...

AI Technical Summary

Benefits of technology

The present invention provides methods, systems, and kits for identifying, assessing, and treating neurological disorders such as multiple sclerosis (MS). The methods involve detecting and measuring disease progression or improvement in a subject by analyzing data on upper and lower extremity function, as well as ambulatory function. The disease status value includes a measure of disease progression or non-progression, and can be used for diagnosis, therapy evaluation, and disease monitoring. The methods, systems, and kits provide increased sensitivity and accuracy in evaluating disease progression and can help identify stable disease non-progressors or progressors, or better treatments for relapses or worsening symptoms. The invention can also be used to develop new therapies for MS.

Problems solved by technology

In many areas, nerve fibers are also damaged.

The loss of oligodendrocytes leads to a reduction in the capacity to re-myelinate and may result in the loss of trophic factors that support neurons and axons (Bjartmar et al.

However, the EDSS alone is typically insufficient to investigate therapeutic efficacy in progressive forms of MS due to, at least, its limited sensitivity in the higher EDSS range where it measures mostly long distance ambulation; a lack of responsiveness to worsening in non-ambulatory functions; and problems inherent to the EDSS scale due to, e.g., random variation, lack of linearity, and measurement errors.

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